FSP CRA (Level II)

Job Description

Join Us as a Clinical Research Associate (Level II) – Make an Impact at the Forefront of Innovation

We have successfully supported the top 50 pharmaceutical companies and more than 750 biotechs, spanning 2,700 clinical trials across 100+ countries in the last 5 years.

As part of our global FSP team, you will perform and coordinate all aspects of clinical monitoring and site management activities in close collaboration with the sponsor. As a Clinical Research Associate (Level II), you will conduct both on-site and remote monitoring visits to ensure protocol and regulatory compliance, as well as proper documentation.

Acting as a site management specialist, you will ensure that clinical trials are conducted in accordance with the approved protocol, ICH-GCP guidelines, applicable local regulations, and SOPs. You will play a key role in ensuring subject safety, data integrity, and inspection readiness, while building strong relationships with investigational sites and sponsor stakeholders.

What You’ll Do

• Perform on-site and remote monitoring visits using a risk-based monitoring approach, including SDV, SDR, and source data review as applicable
• Apply root cause analysis (RCA), critical thinking, and problem-solving skills to identify site issues and implement corrective and preventive actions
• Ensure investigational sites comply with protocol, ICH-GCP, and applicable local regulatory requirements
• Review investigational product accountability, including physical inventory and documentation
• Prepare monitoring visit reports, follow-up letters, and other documentation in a timely and high-quality manner
• Escalate issues and follow through to resolution in collaboration with the CTM and sponsor team
• Maintain regular communication with sites between visits to ensure ongoing compliance and data quality
• Participate in site selection, site initiation, routine monitoring, and close-out activities
• Ensure essential documents are complete and maintained in compliance with ICH-GCP and applicable regulations
• Update study systems (e.g. CTMS) and provide study progress updates to the CTM as required
• Facilitate effective communication between investigational sites, sponsor, and internal project teams
• Support audits and inspections by ensuring audit readiness at site level
• Complete administrative tasks (e.g. expense reports, timesheets) in a timely manner
• Contribute to process improvements and team initiatives as applicable

Education and Experience Requirements

• Bachelor’s degree in life sciences or a related field, or Registered Nurse qualification
• Minimum 1–2 years of clinical monitoring experience (or equivalent), or completion of a recognized CRA training program
• Experience working in an FSP or sponsor-dedicated model is preferred
• Experience in site management and monitoring within Singapore is preferred
• Familiarity with local regulatory requirements (e.g. HSA) and site practices is an advantage
• Valid driver’s license is preferred (if applicable)

Knowledge, Skills and Abilities

• Solid clinical monitoring skills with understanding of risk-based monitoring concepts
• Working knowledge of ICH-GCP, local regulatory requirements, and clinical trial processes
• Strong critical thinking and problem-solving skills
• Effective communication skills in English (additional regional language skills are a plus)
• Strong stakeholder management skills, including working with sponsor teams
• Good organizational and time management skills
• Attention to detail and commitment to quality
• Ability to work independently and collaboratively in a team environment
• Proficiency in Microsoft Office and ability to learn relevant systems

Working Conditions and Environment

• This is a hybrid role, combining home-based work with on-site monitoring visits
• Regular travel to investigational sites within Singapore
• Occasional presence at sponsor or office locations may be required
• Work may involve exposure to clinical environments